FDA.reportPublic FDA data

Application 211489

Type
ANDA
Sponsor
AUROBINDO PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEDAPAGLIFLOZIN; METFORMIN HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL5MG;500MGNoNo
002DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEDAPAGLIFLOZIN; METFORMIN HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL5MG;1GMNoNo
003DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEDAPAGLIFLOZIN; METFORMIN HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL10MG;500MGNoNo
004DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEDAPAGLIFLOZIN; METFORMIN HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL10MG;1GMNoNo
005DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEDAPAGLIFLOZIN, METFORMIN HYDROCHLORIDETABLET2.5MGNoNo